Skip to main content
OpenTrials
Completed

NCT Number: NCT05508087

Cardiovascular Diagnostic in Assessment of Risk HDS and HCT in Patients With Haemoblasts.

In this research we investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sechenov University

Moscow, Russia

About this study

Cancer and cardiovascular (CV) disease are the most prevalent diseases in the developed world. Evidence increasingly shows that these conditions are interlinked through common risk factors, coincident in an ageing population, and are connected biologically through some deleterious effects of anticancer treatment on CV health. Anticancer therapies can cause a wide spectrum of short- and long-term cardiotoxic effects such as heart failure, arrhythmias, systolic and diastolic dysfunction, valvular disease, pericarditis, myocarditis, ischemic heart disease, cardiomyopathy, stroke, hypertension.

A number of studies have shown that autologous and allogeneic hematopoietic cell transplantation (HCT) contribute to an increased incidence of cardiovascular disease (CVD) and worsening of cardiovascular risk factors (CVRFs) that could contribute to further CVD over time. These observations combined with a notable increase in the number of survivors after HCT in recent years highlight the need for studies aimed at modifying risk or preventing these outcomes by changing specific approaches and/or post-HCT interventions.

The aim of this study is to evaluate the prognostic value of cardiological diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.

This is an observational, prospective single- centre, non-randomized study. In this research included patients with haemoblasts. Before and after hematological treatment, all patients undergo a cardiological examination, including examination, history taking, measurement of blood pressure, as well as instrumental examination, including ECG, echocardiography with the determination of global longitudinal deformation, cardiopulmonary pulmonary test, assessment of endothelial function by Angioscan. In addition, all subjects take blood for troponin T and NT-proBNP.

Patients were followed-up from 3 to 12 month after hematopoietic cell transplantation.

In this study was included patients with confirmed hemoblastosis. Written informed consent was obtained from all subjects.

Inclusion criteria

were being over 18 yers of age and expected for high dose chemotherapy and hematopoietic cell transplantation, Exclusion criteria were patient's refusal.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject being over 18 yers of age
  • Subject expected for high dose chemotherapy and hematopoietic cell transplantation

Exclusion criteria

  • Subject's refusal

Treatment and study plan

electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan

Diagnostic Test

We use electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.

Primary outcomes

  1. Cardiac death

    Time frame: Up to 5 years or in the moment of hematopoietic cell transplantation

    Cardiac death after hematopoietic cell transplantation

  2. Death

    Time frame: Up to 5 years or in the moment of hematopoietic cell transplantation

    Death after hematopoietic cell transplantation

Secondary outcomes

  1. All cardiovascular complications

    Time frame: Up to 5 years or in the moment of hematopoietic cell transplantation

    Cardiovascular complications after hematopoietic cell transplantation

Other outcomes

  1. Change ejection fraction by 10% of the original

    Time frame: Through study completion, an average of 5 years after hematopoietic cell transplantation

    Change ejection fraction by 10% of the original after hematopoietic cell transplantation

  2. Change GLS by 12% of the original

    Time frame: Through study completion, an average of 5 years after hematopoietic cell transplantation

    Change GLS by 12% of the original after hematopoietic cell transplantation

  3. Development of diastolic dysfunction

    Time frame: Through study completion, an average of 5 years after hematopoietic cell transplantation

    Development of diastolic dysfunction after hematopoietic cell transplantation

  4. Change anaerobic threshold<9,5 ml/kg/min

    Time frame: Through study completion, an average of 5 years after hematopoietic cell transplantation

    Change anaerobic threshold<9,5 ml/kg/min before and after hematopoietic cell transplantation

  5. Change NTproBNP >125 mmol/l

    Time frame: Before and through study completion, an average of 5 years after hematopoietic cell transplantation

    Change NTproBNP >125 mmol/l before and after hematopoietic cell transplantation

  6. Change Troponin T>14 pg/ml

    Time frame: Before and through study completion, an average of 5 years after hematopoietic cell transplantation

    Change Troponin T>14 pg/ml before and after hematopoietic cell transplantation

  7. Change GLS <18%

    Time frame: Before hematopoietic cell transplantation

    Change GLS <18% before hematopoietic cell transplantation

  8. Change ejection fraction <52%

    Time frame: Before hematopoietic cell transplantation

    Change ejection fraction <52% before hematopoietic cell transplantation

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Cardiovascular Diagnostic in Assessment of Risk High Dose Chemotherapy and Hematopoietic Cell Transplantation in Patients With Haemoblasts.

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2022
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.